Drug Product Manager

Responsibilities

• Responsible for the whole-process management of production materials, consumables, semi-finished products and finished products in strict accordance with GMP requirements
• Mastery of the principles of DP equipment, familiarity with the production process, you may be able to operate equipment independently and perform basic maintenance of related equipment
• In accordance with GMP requirements, draft and revise related operating procedures, batch production records and related files
• Strictly adhere to change control and deviation investigation process, organize the drafts and implementation of changes, conduct deviation investigations, and establish corrective and preventive actions
• Analyze and solve problems arising in the manufacturing process independently and understand how to contribute to solving problems and optimizing the process through literature review
• Continuously optimize production processes and workflows to ensure production quality and improve production efficiency
• Familiar with project production and transfer processes, capable of conducting gap analysis and project transfer
• As a project lead, communicate internally and externally with other departments and clients to ensure the effective implementation of the project and solve the problems arising in the project
• Participate in designing and recommending new plants
• Participate in audits related to DP manufacturing
• Adherence to company compliance requirements

Qualifications

• Bachelor’s Degree with a major in any of the relevant disciplines: Pharmaceutical Manufacturing, Pharmaceutical Engineering, Pharmacy, Bioengineering, Biotechnology, Chemical Engineering, Microbiology, etc.
• Knowledge of GMP is preferred, and expertise in aseptic production is an advantage.
• Solid foundational knowledge in pharmacy and biotechnology, with proficiency in Microsoft Office.
• Good English language skills, literature review skills, and a proactive approach to problem-solving in the workplace.
• Strong hands-on operational ability, with careful and conscientious equipment operation and timely record-keeping.
• Good communication and presentation skills.
• Strong team collaboration, efficient execution, and a great sense of ownership.